LACTATED RINGERS- s odium chloride, s odium lactate, potas s ium chloride, calcium

chloride irrigant
Baxter Healthcare Corporation
----------

DESCRIPTION
Lactated Ringer’s Irrigation
Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium
Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to
7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

INDICATIONS AND USAGE

Is otonic s olution for irrigation only. Not for injection.

DOSAGE AND ADMINISTRATION

As directed by a physician.
Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of
warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

HOW SUPPLIED
Recommended storage: Room temperature (25°C). Avoid excessive heat.

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

 Container Label

2F7154
NDC 0338-0114-04
1000 mL
Baxter Logo
Not for Injection
Lactated Ringer's
Irrigation
Each 100 mL contains: 600 mg Sodium Chloride,
USP, 310 mg Sodium Lactate, 30 mg Potassium
Chloride, USP, 20 mg Calcium Chloride, USP. No
antimicrobial agent has been added. pH 6.5 (6.0 to
7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, non-
pyrogenic. Pour Bottle. Is otonic s olution for irrigation
only. Dosage and Administration: As directed by a
physician. Cautions: Warm in oven to not more than
50°C for a maximum of 60 days. Discard after 60
days of warming. Do not use unless solution is clear
and seal is intact. Discard unused portion. Rx only.
Recommended storage: Room temperature (25°C).
Avoid excessive heat.
PL 325 plastic
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA
Bar Code Position Only*
303380114047
LOT
EXP
07-09-64-077

Carton Label

Lactated Ringer's
Irrigation
Pour Bottle
1000 mL
Qty
12
NDC 0338-0114-04
2F7154
EXP
LOT#
(01)50303380114042(17)080630(10)G012345
07-06-47-995

LACTATED RINGERS
sodium chloride, sodium lactate, potassium chloride, calcium chloride irrigant
 Product Information
Prod uct T yp e HUMAN PRESCRIPTIO N DRUG Ite m Cod e (S ource ) NDC:0 338 -0 114

Route of Ad minis tration IRRIGATIO N

Active Ing redient/Active Moiety

Basis o f
Ing redient Name Streng th
Streng th
SO DIUM CHLO RIDE (UNII: 451W47IQ 8 X) (SO DIUM CATIO N - UNII:LYR4M0 NH37, CHLO RIDE SO DIUM 6 0 0 mg
IO N - UNII:Q 32ZN48 6 9 8 ) CHLO RIDE in 10 0 mL
SO DIUM LACTATE (UNII: TU7HW0 W0 Q T) (LACTIC ACID - UNII:33X0 4XA5AT, SO DIUM SO DIUM 310 mg
CATIO N - UNII:LYR4M0 NH37) LACTATE in 10 0 mL
PO TASSIUM 30 mg
PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ 9 8 I10 ) (PO TASSIUM CATIO N - UNII:29 5O 53K152)
CHLO RIDE in 10 0 mL
CALCIUM 20 mg
CALCIUM CHLO RIDE (UNII: M4I0 D6 VV5M) (CALCIUM CATIO N - UNII:2M8 3C4R6 ZB)
CHLO RIDE in 10 0 mL

Inactive Ing redients

Ing redient Name Streng th
WATER (UNII: 0 59 Q F0 KO 0 R)

Packag ing
# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:0 338 -0 114-0 4 12 in 1 CARTO N
1 10 0 0 mL in 1 BO TTLE, PLASTIC

Marketing Information
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
NDA NDA0 18 49 4 0 2/19 /19 8 2

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name Ad d re s s ID/FEI Bus ine s s Op e rations
Ba xte r He a lthc a re Co rpo ra tio n 0 0 1728 0 59 MANUFACTURE

Revised: 6/2012 Baxter Healthcare Corporation